# Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC, Annex I

Extent: E+W+S+N.I.

No
Reference of the standard
1.
EN 556-1:2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006
2.
EN 556-2:2015
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
3.
EN 1041:2008
Information supplied by the manufacturer of medical devices
4.
EN ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-1:2009/AC:2010
5.
EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
6.
EN ISO 10993-4:2009
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
7.
EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
8.
EN ISO 10993-6:2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
9.
EN ISO 10993-7:2008
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
EN ISO 10993-7:2008/AC:2009
10.
EN ISO 10993-9:2009
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
11.
EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
12.
EN ISO 10993-12:2012
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
13.
EN ISO 10993-13:2010
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
14.
EN ISO 10993-16:2010
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
15.
EN ISO 10993-17:2009
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
16.
EN ISO 10993-18:2009
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
17.
EN ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
18.
EN ISO 11137-1:2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 11137-1:2015/A2:2019
19.
EN ISO 11137-2:2015
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
20.
EN ISO 11138-2:2009
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
21.
EN ISO 11138-3:2009
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
22.
EN ISO 11140-1:2009
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
23.
EN ISO 11607-1:2009
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
24.
EN ISO 11737-1:2006
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
EN ISO 11737-1:2006/AC:2009
25.
EN ISO 11737-2:2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
26.
EN ISO 13408-1:2015
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
27.
EN ISO 13408-2:2018
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
28.
EN ISO 13408-3:2011
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
29.
EN ISO 13408-4:2011
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
30.
EN ISO 13408-5:2011
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
31.
EN ISO 13408-6:2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
32.
EN ISO 13408-7:2015
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
33.
EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 13485:2016/AC:2018
34.
EN ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
EN ISO 14155:2011/AC:2011
35.
EN ISO 14937:2009
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
36.
EN ISO 14971:2012
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
37.
EN ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
38.
EN ISO 17665-1:2006
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
39.
EN ISO 25424:2019
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
40.
EN 45502-1:1997
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
41.
EN 45502-2-1:2003
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
42.
EN 45502-2-2:2008
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
EN 45502-2-2:2008/AC:2009
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
43.
EN 45502-2-3:2010
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
44.
EN 60601-1:2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
EN 60601-1:2006/AC:2010
EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)
45.
EN 60601-1-6:2010
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
46.
EN 62304:2006
Medical device software - Software life-cycle processes (IEC 62304:2006)
EN 62304:2006/AC:2008
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

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Source: https://www.legislation.gov.uk/eudn/2020/438/annex/I (the official version)
Page: https://openlegislation.uk/eu-decision-2020-438/annex-I
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.